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BSI BS EN ISO 10993-7:2026

Biological evaluation of medical devices -- Ethylene oxide sterilization residuals
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BSI BS EN ISO 10993-7:2026

Biological evaluation of medical devices -- Ethylene oxide sterilization residuals

PUBLISH DATE 2026
PAGES 138
BSI BS EN ISO 10993-7:2026
This document specifies allowable limits (AL) for residual ethylene oxide (EO) and ethylene chlorohydrin (ECH) in EO-sterilized medical devices, procedures for the measurement of EO and ECH, and methods for determining conformity so that devices can be released. Additional background, including guidance and a flowchart showing how this document is applied, are also included in Annexes A, B, C, D, E, F, G, H, I, J and K. EO-sterilized devices or components that have neither direct nor indirect body or user contact (e.g. in vitro diagnostic devices) are out of scope of this document. This document does not apply to devices that have been demonstrated to not absorb or retain EO or its degradation product ECH, such as medical devices made exclusively of metal alloys and glass, see Clause C.5[228]. NOTE            This document does not specify limits for ethylene glycol (EG). No device limits are specified for EG because the risk assessment in Annex F indicates that calculated allowable levels are higher than those likely to occur in a medical device.
SDO BSI: British Standards Institution
Document Number ISO 10993-7
Publication Date June 9, 2026
Language en - English
Page Count 138
Revision Level
Supercedes
Committee CH/194
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